A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
- Registration Number
- NCT05736965
- Lead Sponsor
- Shanghai Tong Ren Hospital
- Brief Summary
This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia.
- Detailed Description
This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia.
Selinexor will be given orally at 60mg, d3,10,17 Azacitidine will be given at 75mg/m2, d1-3, 8-9, 15-16 Venetoclax will be given orally at 100mg on day 1 and 200mg on day 2, 400mg on day 3-14
28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
-
Known and written informed consent voluntarily
-
Age ≥ 18 years
-
Newly diagnosed AML patients (per WHO 2022 classification criteria for AML diagnosis), who are not suitable for intensive chemotherapy:
- ≥75 years or
- Aged 18 to 74 years with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3 or 4; Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction <= 50% or chronic stable angina; Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced Expiratory Volume in 1 second (FEV1) <= 65%; Creatinine clearance >= 30 mL/min to < 45 ml/min; Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit of Normal (ULN); Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy .
-
patients who are suitable for intensive chemotherapy but refuse it
-
Liver function meets the following criteria:
aspartate aminotransferase (AST) ≤ 3.0×ULN*; alanine aminotransferase (ALT) ≤ 3.0×ULN*; Bilirubin≤1.5×ULN*; For subjects <75 years old, the bilirubin level can be ≤3.0×ULN;
-
Unless due to leukemic organ involvement.
- Renal function meets the following criteria: creatinine clearance ≥ 30 mL/min (Cockroft-Gault formula)
- Life expectancy ≥ 4 weeks
- History of any malignancies prior to study entry with exception noted in the protocol.
- Participant has known HIV infection, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) .
- Participant has known active central nervous system (CNS) involvement with AML.
- Must not have received prior anti-AML treatment except for hydroxyurea
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SAV arm Selinexor Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy or who refuse to receive intensive chemotherapy will receive selinexor in combination with azacitidine and venetoclax, 28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive SAV regimen until disease progression or unacceptable toxic effects. SAV arm Venetoclax Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy or who refuse to receive intensive chemotherapy will receive selinexor in combination with azacitidine and venetoclax, 28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive SAV regimen until disease progression or unacceptable toxic effects. SAV arm Azacitidine Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy or who refuse to receive intensive chemotherapy will receive selinexor in combination with azacitidine and venetoclax, 28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive SAV regimen until disease progression or unacceptable toxic effects.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Composite Complete Remission From the study start up to death (up to approximately 2 years; ) composite complete remission(CR , CRh, CRi) was calculated based on ELN2022 criteria.
- Secondary Outcome Measures
Name Time Method Overall response rate(ORR) From the study start up to death (up to approximately 4 years; ) Recurrence Free Survival(RFS) From the study start up to death (up to approximately 4 years; ) overall survival (OS) From the study start up to death (up to approximately 4 years; ) percentage of patients who achieved MRD negativity From the study start up to death (up to approximately 4 years; )
Trial Locations
- Locations (19)
Jilin University China Japan Union Hospital
🇨🇳Ch'ang-ch'un, China
Changzhou Municipal No.1 People's Hospital
🇨🇳Changzhou, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Harbin Institute of Hematology and Oncology
🇨🇳Ha'erbin, China
Gansu Provincial People's Hospital
🇨🇳Lanzhou, China
Anhui Provincial Hospital
🇨🇳Hefei, China
the first hospital of Jiaxing affiliated hospital of Jiaxing University
🇨🇳Jiaxing, China
Lanzhou University NO.2 Hospital
🇨🇳Lanzhou, China
Ningbo Medical Center Lihuili Huspital
🇨🇳Ningbo, China
Shanghai Ruijin Hospital
🇨🇳Shanghai, China
Shanghai Tong Ren hospital
🇨🇳Shanghai, China
Yixing People's Hospital
🇨🇳Yixing, China
The First Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, China
The Second Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, China
The First Hospital of China Medical University
🇨🇳Shenyang, China
Xi'an International Medical Center
🇨🇳Xi'an, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, China
the Second Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, China